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RECRUITING

NCT06075823

Edge-to-edge Mitral Valve Repair in ATTR-CM

Sponsor: Medical University of Vienna

View on ClinicalTrials.gov

Summary

No previous study has evaluated the effectiveness of transcatheter edge-to-edge mitral valve repair (TEER) in patients with ATTR-associated cardiomyopathy (ATTR-CM) and significant mitral regurgitation, as this specific patient population was specifically excluded from previous large TEER trials. From a pathophysiological perspective, effective treatment of significant regurgitant volume and consecutive improvement of forward volume appears highly desirable in a condition with intrinsically low output. However, whether this translates into improved functional capacity, better quality of life, and better clinical outcomes compared to conservative heart failure management alone remains to be investigated.

Official title: Effectiveness and Safety of Edge-to-edge MItral vaLve Repair in Patients With Significant mitraL rEgurgitatioN aNd cardIac ATTR amyLoidosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2024-01-01

Completion Date

2028-12-12

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Mitral Regurgitation ATTR-Cardiomyopathy Edge-to-Edge Mitral Valve Repair

Interventions

DEVICE

TEER

Transcatheter edge-to-edge mitral valve repair under general anaesthesia with transoesophageal echocardiographic and fluoroscopic guidance; up to three newer-generation MitraClip (NTR, XTR; Abbott) or PASCAL (Edwards Lifesciences) devices to maximally reduce mitral regurgitation. Intraprocedural invasive haemodynamic measurements before and after device deployment.

OTHER

Optimal Medical Therapy

Optimal medical therapy according to the current understanding of heart failure management in ATTR-CM (careful volume management, rate/rhythm control in atrial fibrillation, anticoagulation where indicated). ATTR-specific therapy (e.g. tafamidis, acoramidis) is allowed but not mandatory in both arms at the discretion of the treating physician; all heart failure and ATTR-specific medication is recorded at every visit.

Inclusion criteria (all must be present) * Proven ATTR-CM * Significant symptomatic MR (3+ or 4+ by independent echocardiographic core laboratory assessment) * Subject has been adequately treated per applicable standards, including for coronary artery disease and heart failure (e.g., diuretics) * New York Heart Association (NYHA) functional class II, III, or ambulatory IV * Local heart team has determined that mitral valve surgery will not be offered as a treatment option, even if the subject is randomized to the control group * Left ventricular ejection fraction ≥20% * Anatomical feasibility for TEER as per discretion of the implanting investigator * Age 18 years or older * Subject or guardian agrees to all provisions of the protocol, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent Exclusion criteria (all must be absent) * AL-associated cardiomyopathy * Aortic valve disease requiring surgery or transcatheter intervention * Severe right ventricular dysfunction * Hemodynamic instability requiring inotropic support or mechanical heart assistance * Leaflet anatomy which may preclude TEER, proper device positioning on the leaflets or sufficient reduction in mitral regurgitation by TEER * Life expectancy \<12 months due to non-cardiac conditions * Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure * Echocardiographic evidence of intracardiac mass, thrombus or vegetation * Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated) * Active infections requiring current antibiotic therapy * Transesophageal echocardiography (TEE) is contraindicated or high risk * Pregnant or planning pregnancy within next 12 months * Currently participating in another investigational device study that has not reached its primary endpoint

Locations (10)

Medical University of Graz, Division of Cardiology

Graz, Austria

Ordensklinikum Linz Elisabethinen, Internal Medicine 2, Cardiology

Linz, Austria

University Hospital St. Pölten, Department of Internal Medicine 3

Sankt Pölten, Austria

Clinic Favoriten, 5th Medical Department, Cardiology

Vienna, Austria

Medical University of Vienna

Vienna, Austria

Hannover Medical School, Department of Cardiology and Angiology

Hanover, Germany

University Hospital Heidelberg, Department of Cardiology, Angiology and Respiratory Medicine

Heidelberg, Germany

LMU University Hospital, Department of Medicine I

München, Germany

ASST Papa Giovanni XXIII, Cardiovascular Department

Bergamo, Italy

ASST Spedali Civili di Brescia, Cardiology

Brescia, Italy